Nizatidine 150mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Nizatidine

Mevcut itibaren:

Mawdsley-Brooks & Company Ltd

ATC kodu:

A02BA04

INN (International Adı):

Nizatidine

Doz:

150mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 01030100

Bilgilendirme broşürü

NIZATIDINE 150 MG & 300 MG CAPSULES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you personally and you should
not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
IN THIS LEAFLET:
1.
Nizatidine; What it is and what it's used for
2.
Before you take Nizatidine
3.
How to take Nizatidine
4.
Possible side effects
5.
Storing Nizatidine
The name of your medicine is Nizatidine 150 mg or 300 mg Capsules.
•
The active ingredient is nizatidine.
•
Other ingredients are pregelatinised starch, dimeticone, povidone,
magnesium stearate, gelatin, titanium dioxide (E171), red, black and
yellow iron oxide (E172) and shellac.
1.
NIZATIDINE; WHAT IT IS AND WHAT IT'S USED FOR
•
Each capsule contains either 150 or 300 mg of nizatidine. Nizatidine
belongs to a group of medicines called H
2
antagonists, which reduce
the amount of acid in the stomach
•
The 150 mg capsules are available in pack sizes of 30 capsules.
The 300 mg capsules are available in pack sizes of 30 capsules
•
Your medicine is used to treat ulcers of the stomach and small
intestine (duodenum), including those caused by non-steroidal
anti-inflammatory drugs (NSAIDS) e.g. ibuprofen, diclofenac.
It is also used to prevent these ulcers from recurring and in the
treatment of reflux disease (heartburn).
2.
BEFORE YOU TAKE NIZATIDINE
DO NOT TAKE NIZATIDINE IF YOU:
•
Are allergic to any of the ingredients in your medicine or have a
known sensitivity to H
2
-receptor antagonists e.g. cimetidine.
TAKE SPECIAL CARE WITH NIZATIDINE IF YOU HAVE:
•
kidney problems
•
Liver problems.
PREGNANCY AND BREAST-FEEDING:
•
Nizatidine is not recommended if you are pregnant, breast-feeding,
or planning on becoming pregnant.
BE CAREFUL IF YOU ARE TAKING:
•
Very high doses of salicylates e.g. aspirin, as nizatidine may
increase
their absorption l

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nizatidine 150mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150mg of nizatidine
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Hard capsule
No. 2 white / orange hard gelatine capsule imprinted axial “NTD”
on the cap
and “150” on the body with black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the following diseases where reduction of gastric
acid is
indicated:
Duodenal ulcer
Benign gastric ulcer
Prevention of duodenal or benign gastric ulcer recurrence
Gastric oesophageal reflux disease (including erosions, ulcerations
and
associated heartburn)
Gastric and/or duodenal ulcer associated with concomitant use of
non-steroidal
anti-inflammatory drugs
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults:_ For treatment of duodenal ulcer, the recommended daily dose
is
300mg in the evening. Treatment should continue for four weeks,
although
this period may be reduced if healing is confirmed earlier by
endoscopy. Most
ulcers will heal within four weeks, but if complete ulcer healing has
not
occurred after four weeks therapy, patients should continue therapy
for a
further four weeks.
For the treatment of benign gastric ulcer, the recommended daily dose
is
300mg in the evening for four or, if necessary, eight weeks. Prior to
treatment
with nizatidine, care should be taken to exclude the possibility of
gastric
cancer.
If preferred, the 300mg daily dose for the treatment of duodenal or
benign
gastric ulcer may be given as two divided doses of 150mg in the
morning and
evening.
For the prevention of duodenal or benign gastric ulcer recurrence
(prophylactic
maintenance therapy) the recommended daily dose is 150mg in the
evening.
For the treatment of gastric oesophageal reflux disease, the
recommended
dosage is from 150mg twice daily, up to 300mg twice daily. Therapy for
up to
12 weeks is indicated for erosions and ulcerations, and associated
heartburn.
For the treatment o